Early Breast Feeding and Glucose Levels in High Risk Newborns - Full Text View

Purpose

Early breast feeding has shown to be important to mother-infant bonding and is associated with longer duration of breast feeding. However, little data is available regarding its contribution to glucose levels in the newborn infants. Newborns that are at risk to develop hypoglycemia may benefit from early breast feeding if this appears to prevent post-partum hypoglycemia.

Condition

Neonatal Hypoglycemia

MedlinePlus related topics:

Breast Feeding Hypoglycemia

ChemIDplus related topics:

Dextrose

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Official Title:	Does Early Breast Feeding Prevents Neonatal Hypoglycemia in High Risk Newborns

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:

normal neonatal glucose levels [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Hypoglycemia prevention [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	100
Study Start Date:	June 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Detailed Description:

Mothers will be encouraged to breast feed early after delivery (at the delivery room). Data of high risk babies for developing post partum hypoglycemia (Infants of diabetic mothers, infants of hypertensive mothers, infants with birth weight more than 4 Kg or less than 2.5 Kg and infants with meconium stained amniotic fluid)will be recorded including maternal breast feeding times and quality of feeding. Glucose levels shall be routinely monitored and recorded at the neonatal department. A comparison of all data will be made between those newborns that breast feed after labor and those who were not.

Eligibility

Ages Eligible for Study:	up to 1 Day
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

primary clinic clinic

Criteria

Inclusion Criteria:

Newborns to diabetic mothers
Newborns to hypertensive mothers
Newborns with birth weight greater than 4 Kg or less than 2.5 Kg
Newborns with meconium stained amniotic fluid

Exclusion Criteria:

Newborns with major congenital malformation
Preterm babies
Newborns with post-birth distress

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00332449

Contacts


Contact: Ayala Maayan, MD	972-3-530-2043	ayala.maayan@sheba.health.gov.il

Locations


Israel, Tel-Hashomer
	Sheba Medical Center - Neonatal Department	Recruiting
	Ramat Gan, Tel-Hashomer, Israel, 52621
	Contact: Ayala Maayan, MD 972-3-530-2451 ayala.maayan@sheba.health.gov.il
	Contact: ayala Maayan, MD 972-3-530-2451 ayala.maayan@sheba.health.gov.il

Sponsors and Collaborators

Sheba Medical Center

Investigators


Principal Investigator:	Ayala Maayan-Metzger, MD	Sheba Medical Center

More Information

Responsible Party:	Sheba Medical Center ( Dr. Ayala Maayan )
Study ID Numbers:	SHEBA-06-4112-AM-CTIL, No
First Received:	May 31, 2006
Last Updated:	April 14, 2008
ClinicalTrials.gov Identifier:	NCT00332449
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:

early breast feeding

hypoglycemia

newborn

Study placed in the following topic categories:

Metabolic Diseases

Metabolic disorder

Glucose Metabolism Disorders

Hypoglycemia

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Sheba Medical Center
Information provided by:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00332449